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Job Title:  Regulatory Affairs Officer (Fresher Job Opportunities)

Organisation: Abacus Pharma Limited

Duty Station: Kampala, Uganda

About US:

Abacus Pharma Limited is the leading distributor and manufacturer of pharmaceutical products in the East Africa region, with its head quarter in Uganda. Abacus distributes a variety of pharmaceutical products that cover the therapeutic areas; Cardio-vascular drugs, Respiratory, Anti-infective, Dermatology, Metabolic disorder, Pain management, Gastro Instestinal, Vaccines, Fertility Drugs – IVF, Anti-malarial, Medical Consumables / Sundries, Surgical / Medical Equipment, Neuro-CNS and OTCs (over the counter drugs).

Job Summary:   Participate in manufacturing authorization processes of the facility, marketing authorization processes of the finished products, pharmacovigilance processes and support compliance to other regulatory requirements

Key Duties and Responsibilities:

• Ensuring implementation of company quality policy.
• Work towards achieving defined quality objectives
• Preparation and submission of dossiers for marketing authorization applications.
• Preparation and submission of additional information as may be requested by regulatory authorities.
• Preparation and submission of variation applications to registered products.
• Preparation and submission of applications for manufacturing Licenses.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Maintaining and monitoring/follow up on registration status of all products country wise.
• Maintaining regulatory compliances to pharmacovigilance requirements.
• Addressing regulatory Authorities related pharmacovigilance queries.
• Execution of pharmacovigilance activities such as Medical Information Call Center (MICC), Individual Case Safety Report (ICSR), Periodic Benefit Risk Evaluation Reports (PBRER), signal detection.
• aggregate reporting, label review and regulatory intelligence activity.
• Ensure Safety Data Exchange Agreements (SDEAs) are signed between partners and Apdl for businesses in Uganda & as appropriate.
• Participate in Pharmacovigilance-inhouse training as applicable
• Preparing and maintaining regulatory documentation.
• Ensure safety of classified information
• Ensure that any other duty assigned by HOD is executed

Qualifications, Skills and Experience:

• Honors Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related field.
• At least 2 years of progressive experience, preferably in a busy pharmaceutical or healthcare industry.

Competencies

• Attention to details
• Overall good pharmaceutical knowledge, endeavor for learning and logical explanation to queries
• Analytical Skills
• Computer Skills (PPt, Excel, MS Word and Adobe Acrobat)
• Intermediate level of English and one other local language preferably Luganda.
• Time management skills
• Problem-solving skills
• Presentation skills
• Communication skills
• Innovative / creative skills

How to Apply:

Please submit your CV and academic credentials to apdlug.careers@abacuspharma.com

Deadline: 17th February 2025, at 5:00 PM.

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